TRANSACTIONAL DUE DILIGENCE

FDA Regulatory Counsel provides practical, business-minded due diligence for deal teams. We understand that each transaction comes with its own ecology, and we deliver insight accordingly.

Provide high level industry insight where regulatory issues affect business outcomes

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Review and advise on compliance history and potential vulnerabilities

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Assess regulatory risk in order to support informed business decisions

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Draft credit and purchase agreement language, including R&W, covenants, notice, and post-closing requirements 

Perform target company compliance analyses to support informed business decisions

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Advise on ancillary regulatory requirements (transfers, registrations, contracts)

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Advise on prospective liability from regulatory enforcement or consumer action

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Vet prospective deals based on industry posture and target companies/products

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SCIENTIFIC AND MEDICAL EXPERTISE

FDARC also provides insight on complex matters tied to FDA-regulated products and companies

in corporate and litigation issues.

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Schedule a courtesy consultation about the value we can add to your work.